NCT06401278

Trans Cutaneous Electrical Acupoint Stimulation Versus TENS On Blood Pressure In Primary Hypertension Patients

Trans Cutaneous Electrical Acupoint Stimulation Versus TENS On Blood Pressure And Quality Of Life In Patients With Primary Hypertension

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Tawfik Tawfik Mahmoud Emara · Academic / Other
• Sex: All
• Age: 50 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

To compare between the effects of transcutaneous electrical acupoint stimulation and TENS on blood pressure and quality of life in patients with primary hypertension BACKGROUND: The current American College of Cardiology and the American Heart Association (ACC/AHA) 2017 guidelines define hypertension as systolic BP (SBP) of ≥130 mmHg or diastolic BP (DBP) of ≥80 mmHg. In adults, an increase of 20 mmHg in SBP or 10 mmHg in DBP is associated with more than a two-fold increase in mortality owing to stroke and other cardiovascular diseases. Hypertension accounts for 13% of premature deaths worldwide and is the third leading cause of disability-adjusted life years (Shah et al., 2022). Transcutaneous electrical nerve stimulation of the Neiguan (P6) point with acupressure is possibly affecting the blood pressure by protecting the myocardial tissues and influencing the nervous system through regulating the autonomic nervous system function and reduction in sympathetic activity. (Hassanein et al., 2021). HYPOTHESES There will be no a significant difference between the effects of transcutaneous electrical acupoint stimulation and TENS on blood pressure and quality of life in patients with primary hypertension RESEARCH QUESTION: Is there a significant difference between the effects of transcutaneous electrical acupoint stimulation and TENS on blood pressure and quality of life in patients with primary hypertension? Evaluating equipment, pre-post intervension outcomes: 1. BP by Digital Sphygmomanometer 2. quality of life by The SF-12 health status questionnaire 3. nitric oxide level in blood by nitric Oxide analysis. 4. sleep quality. by Pittsburgh Sleep Quality Index (PSQI) 5. exercise capacity and endurance by Thirty-Second Sit-To-Stand Test (30 STST)

Conditions

• Hypertension
• Quality of Life

Interventions

Type	Name	Description
DEVICE	Transcutaneous electrical acupoint stimulation	It will be performed by using the TENS device on acupoint (TEAS) as the following: The patients will be placed in a relaxed comfortable sitting position with their back well supported. for 40 min three times weekly for a total of 6 weeks.The adhesive electrodes of the TENS device will be placed on the selected acupoint bilaterally Nei-Guan (PC6), Taichong (LR3), and Sanyinjiao (SP6)
DEVICE	Transcutaneous electrical nerve stimulation (group b):	TENS will be applied in the cervicothoracic ganglion region located between the C7 and T4 vertebral processes for 40 min three times weekly for a total of 6 weeks.

Timeline

• Start date: 2024-05-05
• Primary completion: 2024-08-05
• Completion: 2024-08-10
• First posted: 2024-05-06
• Last updated: 2024-05-07

Locations

1 site across 1 country: Egypt